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Feasibility and impact of Creciendo Sanos, a clinic-based pilot intervention to prevent obesity among preschool children in Mexico City.

ABSTRACT: Mexico has the highest adult overweight and obesity prevalence in the Americas; 23.8% of children <5 years old are at risk for overweight and 9.7% are already overweight or obese. Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social (IMSS) clinics.We randomized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care. We recruited 306 parent-child pairs: 168 intervention, 138 usual care. Children were 2-5 years old with WHO body mass index (BMI) z-score 0-3. We measured children's height and weight and parents reported children's diet and physical activity at baseline and 3 and 6-month follow-up. We analyzed behavioral and BMI outcomes with generalized mixed models incorporating multiple imputation for missing values.93 (55%) intervention and 96 (70%) usual care families completed 3 and 6-month follow-up. At 3 months, intervention v. usual care children increased vegetables by 6.3 servings/week (95% CI, 1.8, 10.8). In stratified analyses, intervention participants with high program adherence (5-6 sessions) decreased snacks and screen time and increased vegetables v. usual care. No further effects on behavioral outcomes or BMI were observed. Transportation time and expenses were barriers to adherence. 90% of parents who completed the post-intervention survey were satisfied with the program.Although satisfaction was high among participants, barriers to participation and retention included transportation cost and time. In intention to treat analyses, we found intervention effects on vegetable intake, but not other behaviors or BMI.ClinicalTrials.gov NCT01539070.Comisión Nacional de Investigación Científica del IMSS: 2009-785-120.

SUBMITTER: Martinez-Andrade GO

PROVIDER: S-EPMC3999907 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Feasibility and impact of Creciendo Sanos, a clinic-based pilot intervention to prevent obesity among preschool children in Mexico City.

Martínez-Andrade Gloria Oliva GO Cespedes Elizabeth M EM Rifas-Shiman Sheryl L SL Romero-Quechol Guillermina G González-Unzaga Marco Aurelio MA Benítez-Trejo María Amalia MA Flores-Huerta Samuel S Horan Chrissy C Haines Jess J Taveras Elsie M EM Pérez-Cuevas Ricardo R Gillman Matthew W MW

BMC pediatrics 20140320

<h4>Background</h4>Mexico has the highest adult overweight and obesity prevalence in the Americas; 23.8% of children <5 years old are at risk for overweight and 9.7% are already overweight or obese. Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social (IMSS) clinics.<h4>Methods</h4>We randomized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care. We ...[more]

PMID: 24649831

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Project description:BackgroundHigh levels of childhood obesity have been observed globally over the last three decades. Preschools are promising settings to implement obesity prevention interventions in the early years. The aim of this study was to test the feasibility of a cluster randomised controlled trial of the ToyBox-Scotland preschool obesity prevention intervention.MethodsSix preschools in predominantly deprived areas of Glasgow, UK, were randomised to either the ToyBox intervention (n?=?3) or usual curriculum control group (n?=?3). The intervention ran for 18?weeks from March-June 2018, and consisted of practitioner-led physical activity and sedentary behaviour sessions in preschools, with an additional interactive home component. Primary outcome measures were intervention fidelity, recruitment rates, attrition rates, and compliance with trial procedures. Secondary outcomes were body mass index (BMI) z-score, bioelectrical impedance analysis (BIA), objectively measured physical activity and sedentary time via activPAL accelerometer, and parent-reported home eating, snacking, and water consumption.ResultsThe preschool component of the intervention was implemented with high fidelity (64%), while the home component was implemented with low fidelity (41%). A cluster-level recruitment rate of 10% was achieved, and the individual-level recruitment rate was 18% (42/233 children, mean age 4.4?years; 17 girls). The attrition rate was 14%, and compliance rates varied considerably by the outcome. Compliance was highest for BMI (86%), while 19% of the sample returned valid accelerometer data for both baseline and follow-up and the parental questionnaire response rate was 23%. Both intervention and control groups showed small increases in BMI z-scores at follow-up of 0.02 and 0.06, respectively. Both groups had small decreases in physical activity and increases in sedentary time at follow-up.ConclusionsBefore progression to an effectiveness trial, additional procedures should be considered to improve recruitment rates, compliance with outcome measures, and implementation of the home-based component of the ToyBox-Scotland intervention.Trial registrationISRCTN12831555.

Project description:Although skin cancer is largely preventable, it affects nearly 1 of 5 US adults. There is a need for research on how to optimally design persuasive public health indoor tanning prevention messages.The objective of our study was to examine whether framed messages on indoor tanning behavioral intentions delivered through short message service (SMS) text messaging would produce (1) positive responses to the messages, including message receptivity and emotional response; (2) indoor tanning efficacy beliefs, including response efficacy and self-efficacy; and (3) indoor tanning risk beliefs.We conducted a pilot study of indoor tanning prevention messages delivered via mobile phone text messaging in a sample of 21 young adult women who indoor tan. Participants completed baseline measures, were randomly assigned to receive gain-, loss-, or balanced-framed text messages, and completed postexposure outcome measures on indoor tanning cognitions and behaviors. Participants received daily mobile phone indoor tanning prevention text messages for 1 week and completed the same postexposure measures as at baseline.Over the 1-week period there were trends or significant changes after receipt of the text messages, including increased perceived susceptibility (P<.001), response efficacy beliefs (P<.001), and message receptivity (P=.03). Ordinary least squares stepwise linear regression models showed an effect of text message exposure on self-efficacy to quit indoor tanning (t6=-2.475, P<.02). Ordinary least squares linear regression including all measured scales showed a marginal effect of SMS texts on self-efficacy (t20=1.905, P=.08). Participants endorsed highly favorable views toward the text messaging protocol.This study supports this use of mobile text messaging as an indoor tanning prevention strategy. Given the nature of skin cancer risk perceptions, the addition of multimedia messaging service is another area of potential innovation for disseminating indoor tanning prevention messages.

Project description:Background:In the UK and beyond, public funding is used to commission interventions delivered in public health early years settings aimed at improving health and well-being and reducing inequalities in order to promote school readiness. This is a key setting for obesity prevention programmes, which are often commissioned despite the limited evidence base. The HENRY (Health, Exercise, Nutrition for the Really Young) programme is an 8-week programme delivered to parents of preschool children, designed to support families to optimise healthy weight behaviours. Early evidence suggests that it may be effective, but a robust evaluation using a randomised controlled design has not been conducted. This study begins this process by evaluating the feasibility of conducting a multi-centre definitive trial to evaluate the effectiveness and cost-effectiveness of HENRY to prevent obesity in the early years. Methods:This is a multi-centre, open labelled, two group, prospective, cluster randomised, controlled, feasibility study aiming to recruit 120 parents from 12 children's centres, based in two local authority areas. Within each of the two local authorities, three centres will be randomised to HENRY and three will be randomised to a control arm of standard care (usual provision of services within children's centres). We will explore HENRY commissioning, provision and delivery and assess the feasibility of local authority, centre and parent recruitment, the processes and time required to train and certify staff to deliver the intervention, the potential sources (and associated risk) of contamination and the feasibility of the trial procedures. Research includes a process evaluation, feasibility of cost-effectiveness evaluation, with progression to the definitive trial judged against pre-defined criteria. Discussion:This feasibility study will support the decision to proceed to, and the design of, a future definitive trial, providing an evidence base of an approach to prevent childhood obesity, which has been deemed attractive to all stakeholders, including parents. Given the widespread adoption of the intervention, this has the potential to impact on public health in the UK and beyond. Trial registration:ClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017Protocol date: 25th October 2017Protocol version: 4.0.

Project description:BackgroundCommunity-based obesity prevention interventions are often commissioned despite the limited evidence base. HENRY (Health, Exercise, Nutrition for the Really Young) is a programme delivered to parents of preschool children across the UK. Early evidence suggests that it may be effective, but a robust evaluation has not been conducted. We initiated a systematic evaluation of HENRY by studying the feasibility of conducting a multi-centre definitive trial to evaluate its effectiveness and cost-effectiveness to prevent obesity. Objectives were to assess the feasibility of recruiting local authorities, centres and parents; test processes and time required to train and certify intervention staff; explore HENRY commissioning processes; identify potential sources (and associated impact) of contamination; and consider the feasibility of trial procedures.MethodsWe conducted a multi-centre, open labelled, two group, prospective, cluster randomised, controlled, feasibility study, with embedded process evaluation and pre-defined criteria for progression to definitive trial. We sought to recruit 120 parents from 12 children's centres, across two UK local authority (government) areas. Within each local authority, we planned to randomise three centres to HENRY and three to 'standard care' control. Our plan was to collect data in family homes at baseline and 12 months, including parent and child height and weight, and parent-reported questionnaires on self-efficacy, feeding, eating habits, quality of life and resource use. Contamination, implementation and study acceptability were explored using parent interviews.ResultsWe recruited two local authorities and 12 children's centres within eight months. One hundred and seventeen parents were recruited (average 3.9 parents per programme) and follow-up data were collected from 85% of participants. Process data from 20 parents and 24 members of staff indicate that both would benefit from more detail about their involvement as participants, but that methods were acceptable. Contamination was likely, though the impact of this on behaviour was unclear.ConclusionOur findings indicate that a cluster RCT of HENRY to assess its effect on childhood obesity prevention is feasible. This study has allowed us to design a pragmatic definitive trial with minimal bias, taking account of lessons learnt from conducting evaluation research in public health settings.Trial registrationClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017.

Project description:BACKGROUND:Process evaluation can illuminate barriers and facilitators to intervention implementation as well as the drivers of intervention outcomes. However, few obesity intervention studies have documented process evaluation methods and results. Community-based participatory research (CBPR) requires that process evaluation methods be developed to (a) prioritize community members' power to adapt the program to local needs over strict adherence to intervention protocols, (b) share process evaluation data with implementers to maximize benefit to participants, and (c) ensure partner organizations are not overburdened. Co-designed with low-income parents using CBPR, Communities for Healthy Living (CHL) is a family-centered intervention implemented within Head Start to prevent childhood obesity and promote family well-being. We are currently undertaking a randomized controlled trial to test the effectiveness of CHL in 23 Head Start centers in the greater Boston area. In this protocol paper, we outline an embedded process evaluation designed to monitor intervention adherence and adaptation, support ongoing quality improvement, and examine contextual factors that may moderate intervention implementation and/or effectiveness. METHODS:This mixed methods process evaluation was developed using the Pérez et al. framework for evaluating adaptive interventions and is reported following guidelines outlined by Grant et al. Trained research assistants will conduct structured observations of intervention sessions. Intervention facilitators and recipients, along with Head Start staff, will complete surveys and semi-structured interviews. De-identified data for all eligible children and families will be extracted from Head Start administrative records. Qualitative data will be analyzed thematically. Quantitative and qualitative data will be integrated using triangulation methods to assess intervention adherence, monitor adaptations, and identify moderators of intervention implementation and effectiveness. DISCUSSION:A diverse set of quantitative and qualitative data sources are employed to fully characterize CHL implementation. Simultaneously, CHL's process evaluation will provide a case study on strategies to address the challenges of process evaluation for CBPR interventions. Results from this process evaluation will help to explain variation in intervention implementation and outcomes across Head Start programs, support CHL sustainability and future scale-up, and provide guidance for future complex interventions developed using CBPR. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03334669 . Registered on October 10, 2017.

Project description:BackgroundMothers who identify as Black or African American are more likely to report depressed moods in late pregnancy and early postpartum and have the lowest rates of human milk feeding compared with all other racial groups in the United States. Internet interventions offer the potential to extend preventative and supportive services as they address key barriers, particularly for those navigating the complex and vulnerable early postpartum period. However, there is limited evidence on the feasibility of such interventions for preventing perinatal mental health disorders and improving human milk feeding outcomes in Black mothers.ObjectiveThis pilot study aimed to assess the feasibility and preliminary findings of a web-based cognitive behavioral therapy-based internet intervention, with and without human milk feeding education and support, to prevent perinatal depression and promote human milk feeding in Black mothers.MethodsParticipants were Black-identifying individuals between 20 and 28 weeks of pregnancy with human milk feeding intention and mild to moderate depressive symptoms (Patient Health Questionnaire scores 5-14). Participants were randomized to either Sunnyside, a 6-week cognitive behavioral therapy-based web-based intervention, or Sunnyside Plus, which included additional education and support to promote human milk feeding. Assessments occurred at baseline, third trimester (end of antenatal treatment), 6 weeks postpartum (end of postpartum treatment), and 12 weeks postpartum. The primary focus of this randomized pilot trial was the feasibility and preliminary outcomes of mental health and human milk feeding.ResultsA total of 22 tertiary-educated participants were randomized. The mean number of log-ins was 7.3 (SD 5.3) for Sunnyside and 13.8 (SD 10.5) for Sunnyside Plus. Scores of depression and anxiety measures remained below the clinical threshold for referral to treatment in both groups. All the participants initiated human milk feeding (18/18, 100%). Most participants reported at least some human milk feeding at both 6 and 12 weeks postpartum (6/7, 86%; 11/11, 100%, or 10/10, 100%, for Sunnyside and Sunnyside Plus, respectively).ConclusionsThe results suggest that tertiary-educated Black mothers at risk for perinatal depression and who intended to human milk feed were receptive to and satisfied with a web-based cognitive behavioral therapy-based internet intervention, with and without human milk feeding education and support. Preliminary findings indicate that both Sunnyside and Sunnyside Plus interventions have the potential to affect symptoms of depression, anxiety, and human milk feeding outcomes.Trial registrationClinicalTrials.gov NCT04128202; https://www.clinicaltrials.gov/ct2/show/NCT04128202.

Project description:BACKGROUND:Rigorous evaluations of health sector interventions addressing intimate partner violence (IPV) in low- and middle-income countries are lacking. We aimed to assess whether an enhanced nurse-delivered intervention would reduce IPV and improve levels of safety planning behaviors, use of community resources, reproductive coercion, and mental quality of life. METHODS:We randomized 42 public health clinics in Mexico City to treatment or control arms. In treatment clinics, women received the nurse-delivered session (IPV screening, supportive referrals, health/safety risk assessments) at baseline (T1), and a booster counselling session after 3 months (T2). In control clinics, women received screening and a referral card from nurses. Surveys were conducted at T1, T2, and T3 (15 months from baseline). Our main outcome was past-year physical and sexual IPV. Intent-to-treat analyses were conducted via three-level random intercepts models to evaluate the interaction term for treatment status by time. RESULTS:Between April and October 2013, 950 women (480 in control clinics, 470 in treatment clinics) with recent IPV experiences enrolled in the study. While reductions in IPV were observed for both women enrolled in treatment (OR, 0.40; 95% CI, 0.28-0.55; P?<?0.01) and control (OR, 0.51; 95% CI, 0.36-0.72; P?<?0.01) clinics at T3 (July to December 2014), no significant treatment effects were observed (OR, 0.78; 95% CI, 0.49-1.24; P?=?0.30). At T2 (July to December 2013), women in treatment clinics reported significant improvements, compared to women in control clinics, in mental quality of life (?, 1.45; 95% CI, 0.14-2.75; P?=?0.03) and safety planning behaviors (?, 0.41; 95% CI, 0.02-0.79; P?=?0.04). CONCLUSION:While reductions in IPV levels were seen among women in both treatment and control clinics, the enhanced nurse intervention was no more effective in reducing IPV. The enhanced nursing intervention may offer short-term improvements in addressing safety planning and mental quality of life. Nurses can play a supportive role in assisting women with IPV experiences. TRIAL REGISTRATION:Clinicaltrials.gov ( NCT01661504 ). Registration Date: August 2, 2012.

Dataset Information

Feasibility and impact of Creciendo Sanos, a clinic-based pilot intervention to prevent obesity among preschool children in Mexico City.

Publications

Feasibility and impact of Creciendo Sanos, a clinic-based pilot intervention to prevent obesity among preschool children in Mexico City.

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